Endo International is a global specialty pharmaceutical company dedicated to delivering life-enhancing solutions through innovation and operational excellence. With a focus on improving patients’ lives, Endo’s portfolio encompasses branded and generic pharmaceuticals, specializing in areas like injectable and oral solid dosage forms (OSD). Endo fosters a diverse, equitable, and inclusive culture that celebrates individual uniqueness and empowers its global workforce to drive collective success.
Job Responsibilities
As a Regulatory Affairs Associate based in Chennai or Indore, you will play a vital role in ensuring compliance with global regulatory standards and supporting the company’s pharmaceutical product portfolio. The responsibilities include:
- Regulatory Submission:
- Preparation, review, and submission of amendments and supplements for assigned products, including injectable and OSD dosage forms.
- Compilation and submission of Global Annual Reports.
- Creation of summary documents for regulatory submissions.
- Agency Interactions:
- Preparation, review, and submission of responses to agency queries.
- Document Review:
- Evaluation of stability protocols, reports, and analytical method validation documents.
- Review of raw materials, packaging materials, finished product specifications, and testing procedures.
- Examination of batch records and executed BMR (Batch Manufacturing Records).
- Review of process validation protocols, hold-time studies, and related reports.
- Analysis of product development reports and certificates of analysis to ensure compliance with regulatory requirements.
- Cross-functional Collaboration:
- Coordination with various departments to ensure documents meet regulatory expectations.
Qualifications To excel in this role, candidates should possess the following qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Science, or a related field.
- Proven experience in regulatory affairs, specifically handling injectable and OSD dosage forms.
- Knowledge of global regulatory standards and requirements.
Skills Required
- Strong analytical and problem-solving abilities.
- Proficiency in regulatory documentation and dossier preparation.
- Excellent written and verbal communication skills.
- Attention to detail and commitment to ensuring compliance.
- Ability to manage multiple projects and meet tight deadlines.
